When
Thailand went ahead with a compulsory license on Kaletra, an AIDS drug,
despite threats from Abbott the maker of the drug, the latter hit back
by withdrawing the registration of a new heat stable form of Kaletra
and six other drugs. The likely outcome will be more deaths of innocent
patients.

The
following article describes the situation.

With
best wishesEvelyne HongTWN

Standing Up To Abbott's
Decision to Withhold Registration and Marketing of

Life-Saving Medicines
- A New Variant of Pharmaceutical Apartheid

By Brook K. Baker, Health
GAP, 13 March 2007

Abbott is now doing what
drug companies have long threatened to do when developing countries
use lawful flexibilities to access more affordable generic medicines
- it is threatening to take its marbles and go home. Unfortunately,
however, Abbott is not playing marbles, it is playing a deadly game
of Pharmaceutical Apartheid, where drug companies withhold access to
affordable life-saving medicines in a perverse effort to preserve intellectual
property rights at all costs.

Abbott is upset because Thailand
has lawfully issued a compulsory license on an important antiretroviral
medicine, Kaletra. According to Abbott (and its think-tank apologists
and Wall Street Journal defenders), Thailand issued this license without
prior negotiations for a price discount or for a voluntary license.
However, contrary to Abbott's claim, both international law (the WTO
TRIPS Agreement, Article 31) and the

noncommercial use without
prior negotiation. Moreover, contrary to Abbott's claim, Thailand,
like many other developing countries, had long engaged in fruitless
negotiations with Big Pharma for deeper price discounts, but Abbott
used its monopoly power to unilaterally determine the price points for
its tiered-pricing "access" program.

Because Thailand has not
caved into to threats and entreaties from Abbott, the USTR, certain
members of Congress, and the international business press, Abbott has
now raised the stakes further by withdrawing registration applications
for the new heat stable form of Kaletra, an important AIDS medicine,
and for six other medicines that it had submitted for marketing approval.
(The meltrex, heat stable form of Kaletra is especially important in
warm country climates like Thailand where maintaining a cold-supply
chain and ensuring that poor patients have access to refrigerators to
store their medicines is virtually impossible.)

This withdrawal is profoundly
cynical and immoral. A company which has been subsidized through
NIH and university research for most of its discoveries, which gets
huge taxes breaks for its research and development expenditures, and
which earns monopoly profits on all its sales in rich country markets
that collectively comprise 90% of global pharmaceutical sales, now determines
that it will withhold marketing of life-saving medicines when a country
seeks to exercise its lawful, TRIPS-compliant rights to access more
affordable generic medicines.

This withdrawal will make
it much more difficult for Thailand to grant marketing approval for
generic versions of Kaletra and other Abbott medicines because the Thai
drug regulatory authority will not simply be able to compare the generic
version against the innovator version to confirm that they are therapeutically
equivalent. In the worst case scenario, generic companies will
now have to repeat costly, time-consuming,

and ultimately unethical
clinical trials to prove something that is already crystal clear - equivalent
generic medicines are safe and efficacious. Even if Thailand decides
to forego reliance on new clinical trials, it may instead have to amend
its law so that it can rely on WHO pre-qualification and/or the fact
of registration by a stringent regulatory authority

elsewhere. (Note:
The U.S. is trying to block Thailand's future right to legislate such
reliance in its free trade agreement negotiation where it seeks five-years
of data exclusivity.)

However, even though Abbott
will not necessarily by able to completely block registration of follow-on
generics by its market withdrawals, its withdrawals will have devastating
effects for those medicines for which there is no generic alternative
at present.

Thus, to prove its point,
and to maintain its market and intellectual property hegemony, Abbott
is willing to make Thailand and its patients a "no drug zone." The
predictable, inevitable consequence of this cynical power play will
be the deaths of innocent patients.

Drug companies like Abbott
have all kinds of lame excuses for their murderous policies. Novartis
defends its patent law lawsuit in India because it wants to maintain
its right to sell Glivec to middle-income patients, even though India
represents only 1.3% of the global pharmaceutical market and even though
99% of Indians are not middle class.

Pfizer wants to maintain
its patent monopolies in the Philippines by filing frivolous lawsuits
against government officials and generic companies who seeks to permit
lawful early registration of generic medicines. And now Abbott, pulls
a new "troop-surge" weapon from its arsenal - wholesale market
withdrawals.

Once again activists and
thought leaders need to rally to the support of Thailand's lawful effort
to access more affordable medicines and to condemn this latest variant
of pharmaceutical apartheid. One hopes fervently that Thailand
will stand firm, that it will find alternative ways to grant marketing
approval/registration of generic versions of Pharma products, and that
even more developing countries will stand up and fight for the human
right of access to essential medicines.

Brook K. Baker is a Professor
at Northeastern U. School of Law, USA. Health GAP is a US-based organisation
concerned with global access to affordable and life sustaining medicines
for people living with HIV/AIDs.